A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

Hoffmann-La Roche28 enrolled

Overview

This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Epoetin betaDRUG

Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults at least 18 years of age * Presence of solid tumor(s) * Receiving platinum-based therapy capable of inducing anemia Exclusion Criteria: * Red blood cell transfusion within 7 days prior to study drug * Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug * Women who are pregnant or breastfeeding

Locations (13)

Unnamed facility

Alcoy, Spain

Unnamed facility

Barakaldo, Spain

Unnamed facility

Barcelona, Spain

Unnamed facility

Barcelona, Spain

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: Up to 16 weeks

Secondary Outcomes

Hemoglobin response rate index

Time frame: Up to 16 weeks

Data from ClinicalTrials.gov

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